NCT06369870 Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy
| NCT ID | NCT06369870 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Algemeen Ziekenhuis Maria Middelares |
| Condition | Analgesic Effect |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 144 participants in total. It began in 2024-09-01 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the analgesic effect of locoregional anaesthesia, specifically the interpectoral pectoserratus plane (IPP-PSP) block, in comparison to a placebo (sham block) after Aortic Valve Replacement via Right Anterior Minithoracotomy (AVR-RAT). The main question the trial aims to answer is: Can the IPP-PSP block effectively reduce opioid consumption within the first 48 hours after AVR-RAT surgery? The purpose is to understand the impact of the IPP-PSP block on postoperative pain. Therefore, the aim is to investigate the influence of the IPP-PSP block on the amount of pain medication administered during the patients' first 48 hours after surgery. Participants, who are scheduled for AVR-RAT surgery, will be randomly assigned to receive either the IPP-PSP block or the sham block. Researchers will compare opioid consumption among other outcomes, including differences in pain scores, incidence of nausea and vomiting, quality of recovery, quality of life, and the length of hospital stay between the two groups. Patients will be monitored during their hospitalization, and a follow-up phone call will be conducted 30 days after surgery.
Eligibility Criteria
Inclusion Criteria: * Adult patients (18 years of age or older); * Patients scheduled for minimally invasive aortic valve replacement via right anterior minithoracotomy; * Patients with American Society of Anesthesiologists (ASA) physical status classification II, III or IV; * Patients with European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2 ≤ 4%; * Patient has given written, free and informed consent. Exclusion Criteria: * BMI \> 35; * Patients under legal protection (curatorship, guardianship); * Patients subject to a legal protection measure; * An adult who is incapable or unable to give consent; * Patients requiring emergency surgery within 24 hours; * Chronic opioid use (\> 3 administrations per week or continuous transdermal therapy, longer than the last 3 months); * Patients known with chronic pain; * Patients known with an allergy to levobupivacaine or drugs used as standard of care, including amongst others piritramide, dexamethasone, propofol, remifentanil, rocuronium, acetaminophen, ondansetron; * Patients who receive medication that could possibly interact with levobupivacaine (mexiletine, ketoconazole, theophylline); * Patients who took monoamine oxidase (MAO) inhibitors within the last 2 weeks before surgery; * Patients with chronic renal failure (dialysis dependent, estimated glomerular filtration rate (eGFR) \< 30 ml.min-1.(1,73 m²)-1) ; * Patients with severe hepatic impairment (Model for End-Stage Liver Disease (MELD) score ≥ 20); * Patients with preoperative cognitive dysfunction (Mini Mental State Examination (MMSE) score \< 24); * Patients with uncontrolled epilepsy; * Patients with severe arterial hypotension (Systolic Arterial Pressure (SAP) \< 90 mmHg, cardiogenic shock); * Patients who simultaneously participate in another interventional clinical trial; * Soft tissue infection in the area of the procedure; * Patients who are pregnant, parturient or breast-feeding women; * Patients who are unable to sufficiently speak and write in the Dutch language.
Contact & Investigator
Bart Vaes, MD
PRINCIPAL INVESTIGATOR
Algemeen Ziekenhuis Maria Middelares
Frequently Asked Questions
Who can join the NCT06369870 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Analgesic Effect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06369870 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06369870 currently recruiting?
Yes, NCT06369870 is actively recruiting participants. Contact the research team at bart.vaes@mijnziekenhuis.be for enrollment information.
Where is the NCT06369870 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06369870 clinical trial?
NCT06369870 is sponsored by Algemeen Ziekenhuis Maria Middelares. The principal investigator is Bart Vaes, MD at Algemeen Ziekenhuis Maria Middelares. The trial plans to enroll 144 participants.